Michal Doležal Email and Phone Number

Study-level project management from development of protocol until study reporting. Setup of study budget and budget control. Vendor management (IRT, CRF, PRO, eTMF). Selection of countries, setup of countries and sites. Development of study plans (Quality, Monitoring, Medical, Safety, Data management plans). Management of monitoring teams. Supporting audits and inspections.Therapeutic areas: Gynaecology, Endocrinology

Quality management within a local clinical trial department. SOP management, support of audits and inspections, training management. Participation in pharma association clinical trials working group (AIFP SK).

Clinical trial management on country(ies) level in GCP trials, on trial level for non-interventional studies. Therapeutic areas: Diabetes, Cardiovascular, Immuno&Inflammatory, Oncology, Covid-19.

Site selection, initiation, monitoring and closure in the Czech Republic and Slovakia. Country start-up, regulatory activities, contracting clinical trial sites. Co-monitoring and training.Therapeutic areas: Neurology, Pain, Gynaecology, Pulmology

Sales representative covering approx. 100 customers (diagnostic laboratories). Translation of product-related documents. Training of laboratory staff on the products.